WEDNESDAY, May 5, 2004 (HealthDayNews) -- Giving radiation and chemotherapy to patients with advanced head and neck cancer reduces the risk of a tumor recurrence and, in some cases, also extends their lives.
Two studies appearing in the May 6 issue of the New England Journal of Medicine looked at the same combination regimen and both showed a reduction in recurrence. One also showed a longer survival.
"We consider this to be an important study that adds one more piece of evidence that patient outcome can be improved by coordinated multiple specialties and multiple therapies," said Dr. Walter Curran, group chairman of the Radiation Therapy Oncology Group, which coordinated one of the studies, and clinical director of the Kimmel Cancer Center at Thomas Jefferson University in Philadelphia.
Head and neck cancer is a difficult disease, with almost one third of patients having it spread to distant parts of the body.
Combination radiation and chemotherapy with cisplatin has become common for tumors that are have spread locally but aren't operable, said study author Dr. Jay S. Cooper, head of radiation oncology at Maimonides Medical Center in New York City.
This latest research extended the practice to people who had undergone surgery.
Cooper's trial, which was conducted in the United States, enrolled 459 patients who had had all apparent vestiges of their tumors removed by surgery. The patients were then randomly assigned to receive either radiation on its own or to receive radiation plus cisplatin.
After about two years, 82 percent of the combined therapy group had had no local recurrences compared to 72 percent in the group receiving only radiation. While disease-free survival was longer in the combination group, overall survival was not.
"If you don't find a mathematically statistically significant change, it doesn't mean one doesn't exist," Cooper said. It's possible that, over time, an overall survival would be seen. It's also possible that other lifestyle issues that contributed to the cancer (such as heavy drinking and smoking) caused other problems such as heart disease.
"Even if you do a better job of controlling tumors, it may not translate immediately into better survival because they'll still die of other things," Cooper explained.
The combination therapy was more toxic, with more adverse effects and four patients who died directly as a result of the treatment.
The second trial, which took place in Europe, randomly assigned 167 patients to receive radiation and an equal number to receive radiation plus cisplatin.
Participants in the combination group had higher disease-free survival, with their five-year survival estimated to be 47 percent. For those in the radiation group, the estimate was 36 percent. Overall survival was also higher, with five-year estimates at 53 percent and 40 percent, respectively.
The findings are likely to change clinical practice, Curran predicted. "Up until now, people who track evidence-based oncology would not recommend chemotherapy simultaneous with radiation in postoperative settings for head and neck cancer," he explained. "Now with this study and the study from Europe, they can say there's a disease control benefit to doing it. I think we will see a shift in care to include chemotherapy in the high-risk patients receiving post-operative radiation."
"These two studies report a benefit when chemotherapy in the form of cisplatin is added to postoperative radiation in patients with high-risk head and neck cancer," added Dr. Stephen Shibata, a staff physician in medical oncology and therapeutics and director of the GI Multi-Disciplinary Strategic Program at City of Hope in Duarte, Calif. "Based on this, a combination of chemotherapy and radiation should be considered in patients with head and neck cancers at high risk for local recurrence. One issue is that the addition of chemotherapy leads to more side effects during treatment. Therefore, this treatment may not be appropriate for all patients."
The questions now involve figuring out how much radiation and exactly how to administer the chemotherapy, Cooper said. "At least in theory, there might be other ways to do it, ways that have a lesser cost in terms of toxicity," he noted.